title: Assessment of antigenemia assay for the diagnosis of cytomegalovirus gastrointestinal diseases in HIV-infected patients.
abstract: We conducted a single-center prospective study to evaluate the utility of cytomegalovirus (CMV) antigenemia assay for the diagnosis of CMV-gastrointestinal disease (GID). The study subjects were HIV-infected patients with CD4 count ≤200 μL/cells who had undergone endoscopy. A definite diagnosis of CMV-GID was made by histological examination of endoscopic biopsied specimen. CMV antigenemia assay (C10/C11 monoclonal antibodies), CD4 count, HIV viral load, history of HAART, and gastrointestinal symptoms as measured by 7-point Likert scale, were assessed on the same day of endoscopy. One hundred cases were selected for analysis, which were derived from 110 cases assessed as at high-risk for CMV-GID after endoscopy screening of 423 patients. Twelve patients were diagnosed with CMV-GID. Among the gastrointestinal symptoms, mean bloody stool score was significantly higher in patients with CMV-GID than in those without (2.5 vs. 1.7, p=0.02). The area under the receiver-operating characteristic curve of antigenemia was 0.80 (95%CI 0.64-0.96). The sensitivity, specificity, positive likelihood ratio (LR), and negative LR of antigenemia were 75.0%, 79.5%, 3.7, and 0.31, respectively, when the cutoff value for antigenemia was ≥1 positive cell per 300,000 granulocytes, and 50%, 92.0%, 5.5, and 0.55, respectively, for ≥5 positive cells per 300,000 granulocytes. In conclusion, CMV antigenemia seems a useful diagnostic test for CMV-GID in patients with HIV infection. The use of ≥5 positive cells per 300,000 granulocytes as a cutoff value was associated with high specificity and high positive LR. Thus, a positive antigenemia assay with positive endoscopic findings should allow the diagnosis of CMV-GID without biopsy.
authors.affiliation: AIDS Clinical Center, National Center for Global Health and Medicine, Tokyo, Japan.
authors.forename: Yohei
authors.initials: Y
authors.lastname: Hamada
authors.forename: Naoyoshi
authors.initials: N
authors.lastname: Nagata
authors.forename: Takuro
authors.initials: T
authors.lastname: Shimbo
authors.forename: Toru
authors.initials: T
authors.lastname: Igari
authors.forename: Ryo
authors.initials: R
authors.lastname: Nakashima
authors.forename: Naoki
authors.initials: N
authors.lastname: Asayama
authors.forename: So
authors.initials: S
authors.lastname: Nishimura
authors.forename: Hirohisa
authors.initials: H
authors.lastname: Yazaki
authors.forename: Katsuji
authors.initials: K
authors.lastname: Teruya
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Gatanaga
authors.forename: Yoshimi
authors.initials: Y
authors.lastname: Kikuchi
authors.forename: Junichi
authors.initials: J
authors.lastname: Akiyama
authors.forename: Norio
authors.initials: N
authors.lastname: Ohmagari
authors.forename: Naomi
authors.initials: N
authors.lastname: Uemura
authors.forename: Shinichi
authors.initials: S
authors.lastname: Oka
mesh_terms: D017088:AIDS-Related Opportunistic Infections / Q000175:diagnosis* / Q000276:immunology / Q000821:virology; D000328:Adult; D000956:Antigens, Viral / Q000097:blood* / Q000276:immunology; D019540:Area Under Curve; D001706:Biopsy; D018791:CD4 Lymphocyte Count; D003587:Cytomegalovirus / Q000276:immunology* / Q000302:isolation & purification; D003586:Cytomegalovirus Infections / Q000097:blood / Q000175:diagnosis* / Q000276:immunology; D016099:Endoscopy, Gastrointestinal; D005260:Female; D005767:Gastrointestinal Diseases / Q000097:blood / Q000175:diagnosis / Q000276:immunology / Q000821:virology*; D015658:HIV Infections / Q000175:diagnosis / Q000276:immunology / Q000821:virology*; D006801:Humans; D007564:Japan; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012680:Sensitivity and Specificity; D019562:Viral Load
chemical_list: D000956:Antigens, Viral